A deluge of drug recalls set a record in 2009. With the past four years now among the top five for recalls, it suggests drug quality could be in a period of decline. Last year's record reflects GMP breakdowns at a drug repacker and several manufacturers that were identified during FDA inspections and led to a variety of sanctions, including warning letters, consent decrees and an import alert. Congress is looking to let FDA mandate recalls, which means the rain of recalls could grow even heavier. Meanwhile, FDA adds suspensions to its enforcement arsenal. International recalls remain rare, though that could change as FDA ramps up enforcement abroad
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
A calculation used to determine whether the FDA has the staff to handle its workload also was not included in the description of prescription drug user fee calculations.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
The UK drug regulator and England’s health technology assessment agency have joined forces under an information sharing agreement, aimed at accelerating patient access to newly approved medicines by three to six months.
